Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

NCT00858637 | Completed Phase 3 Results

• 1 other identifier: MCI-196-E11
• Study Type: interventional
• Target: 260
• Locations: 13 countries
• Sites: 39

Brief Summary

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Dialysis; Dyslipidemia; Bile acid sequestrant

Outcome Measures

Primary Outcomes (1)

• Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)

  Percent Change from Week 16 to Week 20 (LOCF)

  week20 minus week16

Secondary Outcomes (3)

• Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)

  week16 minus week0

• Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)

  16 weeks and 20 weeks

• Vital Signs, Adverse Events, and Laboratory Values

  throughout study

Study Arms (4)

1 MCI-196

EXPERIMENTAL

Drug: MCI-196; Drug: Placebo of Simvastatin

2 Placebo of MCI-196

PLACEBO COMPARATOR

Drug: Placebo of Simvastatin; Drug: Placebo of MCI-196

3 Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin; Drug: Placebo of MCI-196

4 Placebo of Simvastatin

PLACEBO COMPARATOR

Drug: Placebo of Simvastatin; Drug: Placebo of MCI-196

Interventions

MCI-196 DRUG

Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®

1 MCI-196

Placebo of Simvastatin DRUG

Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

1 MCI-196; 2 Placebo of MCI-196; 4 Placebo of Simvastatin

Simvastatin DRUG

Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

3 Simvastatin

Placebo of MCI-196 DRUG

Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

2 Placebo of MCI-196; 3 Simvastatin; 4 Placebo of Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, and is \>=18 years old
• Stable hemodialysis or peritoneal dialysis
• Subjects undergoing regular dialysis treatment
• If Female and of child-bearing potential, have a negative serum pregnancy test
• Male subjects must agree to use appropriate contraception

You may not qualify if:

• Serum albumin level \< 30 g/L
• Triglycerides level \> 6.76 mmol/L (600 mg/dL)
• LDL-cholesterol level \> 4.94 mmol/L (190 mg/dL)
• A History of significant gastrointestinal motility problems
• Biliary obstruction or proven liver dysfunction
• A positive test for HIV 1 and 2 antibodies
• A history of substance or alcohol abuse within the last year
• The subject has a history of rhabdomyolysis or myopathy
• Schedule to receive a kidney transplant within the next 6 months
• The subject has porphyria
• Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (39)

Unknown Facility

Brest, Belarus

Location

Unknown Facility

Grodno, Belarus

Location

Unknown Facility

Homyel, Belarus

Location

Unknown Facility

Minsk, Belarus

Location

Unknown Facility

Vitebsk, Belarus

Location

Unknown Facility

Gabrovo, Bulgaria

Location

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Karlovac, Croatia

Location

Unknown Facility

Osijek, Croatia

Location

Unknown Facility

Esbjerg, Denmark

Location

Unknown Facility

Roskilde, Denmark

Location

Unknown Facility

Jakarta, Indonesia

Location

Unknown Facility

Malang, Indonesia

Location

Unknown Facility

Medan, Indonesia

Location

Unknown Facility

Palembang, Indonesia

Location

Unknown Facility

Tamanlarea Makassar, Indonesia

Location

Unknown Facility

Ashkelon, Israel

Location

Unknown Facility

Nahariya, Israel

Location

Unknown Facility

Bellano, Italy

Location

Unknown Facility

Catania, Italy

Location

Unknown Facility

Lecco, Italy

Location

Unknown Facility

Merate, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Oggiono, Italy

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Valmiera, Latvia

Location

Unknown Facility

Kaunas, Lithuania

Location

Unknown Facility

Kedauniai, Lithuania

Location

Unknown Facility

Vilnius, Lithuania

Location

Unknown Facility

George Town, Malaysia

Location

Unknown Facility

Johor Bahru, Malaysia

Location

Unknown Facility

Kelantan, Malaysia

Location

Unknown Facility

Perak, Malaysia

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Timișoara, Romania

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Phitsanulok, Thailand

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Dyslipidemias

Interventions

cholebine; Simvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma Europe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 7, 2026
• Results First Posted: October 17, 2014

Record last verified: 2025-12

Locations

MY (4); LI (3); IT (6); LA (2); BU (3); SG (1); CR (2); ID (5); BE (5); RO (2); DK (2); IL (2); TH (2)